China’s drug regulator is enforcing a simple but consequential rule: every finished traditional Chinese medicine (中成药) must list clear contraindications, adverse reactions and precautions on its label. The requirement, in force since July 1, 2023, included a three‑year transition that ends on July 1, 2026; products that still state “尚不明确” (“unclear”) will be ineligible for registration renewal.
The scale is striking. Of roughly 57,000 approved patent Chinese medicines on the market, regulators say about 70% carry ambiguous wording on safety information — some 40,000 products face delisting unless manufacturers revise their labels. That does not ban traditional medicine; it forces firms to provide explicit safety information or to demonstrate an absence of known harms.
The rule is framed as a quality‑control measure designed to protect patients and tidy up a sprawling market. Regulators, doctors and some analysts point to an online ecosystem in which charismatic influencers promote miracle cures and fast fixes, and where poorly manufactured or mislabelled products can mislead vulnerable people, particularly the elderly.
Opponents immediately characterised the move as a cultural or political attack on Chinese medicine, arguing that centuries of usage should exempt many preparations from modern safety labelling. Supporters counter that traditional use is not a substitute for clear safety information and that firms that can demonstrate no known adverse effects can simply state that on labels; it is the vague “unclear” wording that the regulation targets.
The practical consequences are likely to be uneven. Small manufacturers that lack the resources to update labels or gather adverse‑event data face the greatest risk of being pushed out. Larger, better‑capitalised firms stand to consolidate market share, and those able to invest in pharmacovigilance may benefit from stronger consumer trust and easier access to reimbursement schemes.
Beyond domestic politics and industry consolidation, the shift signals China’s broader move toward aligning some aspects of traditional‑medicine oversight with international pharmacovigilance norms. If implemented carefully, the policy could raise safety standards and bolster confidence among domestic consumers and potential overseas buyers; mishandled, it could fuel nationalist pushback and create short‑term shortages in localities dependent on small producers.